Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2026-03-05 @ 3:43 PM
Study NCT ID:
NCT06470893
Status:
COMPLETED
Last Update Posted:
2025-08-19
First Post:
2024-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Online Exposure Therapy for Obsessive-Compulsive Disorder (OCD) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2024-06-17', 'studyFirstSubmitQcDate': '2024-06-17', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in OCD Symptoms Measured by Yale-Brown Obsessive Compulsive Scale-Second Edition (YBOCS-II)', 'timeFrame': 'Baseline, up to 12 months (end of treatment)', 'description': 'YBOCS-II scores range from 0-50, and higher scores indicate more severe illness'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obsessive-Compulsive Disorder']}, 'descriptionModule': {'briefSummary': 'The overarching goal of this protocol is to investigate mechanisms that influence symptom outcomes of exposure and response prevention (ERP) therapy for OCD. Mechanisms may include affective processes, learning factors, cognitive factors, or other constructs that could influence treatment outcomes. The study team will conduct this research within the context of an effective online treatment for OCD called OCD-NET. OCD-NET is bibliotherapy with coaching and its content is reflective of standard care for OCD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English-speaking\n* Located within the United States\n* 18-90 years old\n* Able to provide consent\n* Current diagnosis of OCD as assessed by clinical interview\n\nExclusion Criteria:\n\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers)\n* Participants currently located outside of the United States\n* Prisoners\n* Participants with hoarding as the primary OCD symptom\n* Severe mental illness (e.g. schizophrenia, substance abuse); organic brain syndrome; or serious, current suicidal/homicidal ideation (based on phone screening or initial assessment)\n* Concurrent enrollment in another psychotherapy treatment\n* Participants taking psychotropic medication may be excluded if:\n\n * They have started a brand new psychotropic medication within the last 12 weeks\n * They have changed the dose of their psychotropic medication within the last 4 weeks\n * They anticipate that they cannot maintain the current dose of their psychotropic medication for the duration of the study\n* Participants may be excluded if they have any cognitive or physical impairments that would interfere with their participation (e.g., significant head injury, cognitive disability, dementia).'}, 'identificationModule': {'nctId': 'NCT06470893', 'briefTitle': 'Online Exposure Therapy for Obsessive-Compulsive Disorder (OCD) Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Online Exposure Therapy for Obsessive-Compulsive Disorder (OCD) Study', 'orgStudyIdInfo': {'id': '20240483'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OCD-NET Group', 'description': 'Participants will receive the OCD-NET intervention for up to 12 months.', 'interventionNames': ['Behavioral: OCD-NET']}], 'interventions': [{'name': 'OCD-NET', 'type': 'BEHAVIORAL', 'description': 'OCD-NET is bibliotherapy with coaching and its content is reflective of standard care for OCD. OCD-NET is a self-paced intervention that participants complete entirely online with the support of an assigned individual therapist. Most participants complete this treatment in up to twelve weeks. On average, participants are expected to spend between one to five hours per week during the first half of treatment. In the second half of treatment when participants begin regular exposure and response prevention (ERP) exercises, participants are expected to spend about one hour per day.', 'armGroupLabels': ['OCD-NET Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33146', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Kiara Timpano, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Miami'}, {'name': 'Amelia Dev, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kiara Timpano', 'investigatorAffiliation': 'University of Miami'}}}}